Cord Blood Banking Leader Cryo-Cell Announces Its Intent to Advance Clinical Trials
27 Octubre 2021 - 3:15PM
Cryo-Cell International, Inc. (The Nasdaq Stock Market
Symbol: CCEL) (the “Company”), the world’s first private
cord blood bank to separate and store stem cells in 1992, announces
further plans for its newly developed Institute for Cellular
Therapies. As a result of the exclusive license agreement signed
with Duke University on February 26, 2021, Cryo-Cell acquired
exclusive commercial rights to a range of intellectual property
assets and FDA regulatory data around several cord blood and cord
tissue derived cell therapy products that had completed Phase
1/Phase 2 clinical trials. With this, Cryo-Cell is working to
develop, as described further below, a pipeline of potential cord
blood- and cord tissue-derived cellular products to be tested in
Phase 2 and Phase 3 randomized, placebo-controlled clinical trials
to further determine safety and efficacy of these products in
babies with hypoxic ischemic encephalopathy, children with cerebral
palsy, children with autism spectrum disorder and other conditions.
Cryo-Cell’s cellular therapies with strong signals in Phase 3
clinical trials are expected to be moved through formal FDA
approval pathways to Biologics License Applications (BLA) and
commercialization.
- Based on the
results of a Phase 1 trial at Duke, Cryo-Cell intends to conduct a
Phase 2 randomized, placebo-controlled trial to test the safety and
efficacy of cord tissue mesenchymal stem cells (MSCs) in
newborns with hypoxic ischemic encephalopathy (HIE).
- Based on results in
Phase 1 and 2 studies of cord blood infusions in children with
cerebral palsy (CP) at Duke, Cryo-Cell may fund a Phase 3
randomized, placebo-controlled trial to confirm the efficacy of a
cord blood infusion in children with CP which, if confirmed, would
lead to a submission for FDA licensure (BLA).
- Cryo-Cell will
support a follow-on randomized, placebo-controlled clinical trial
to validate results in secondary and exploratory endpoints in a
subset of patients on the Duke-ACT Phase 2 clinical trial, which
investigated the benefits of cord blood infusions in children with
autism. The new study is planned to improve upon the design and
eligibility criteria to confirm the positive results of Duke-ACT’s
secondary and exploratory outcomes.
David Portnoy, Chairman of the Board
and Co-CEO, stated, “After several months of careful
evaluation of the results from the early-stage clinical trials
conducted by Duke University, Cryo-Cell believes that those results
justify moving these cord blood and cord tissue cell therapy
products to the next stage of clinical development.”
About Cryo-Cell International, Inc.
Founded in 1989, Cryo-Cell International, Inc.
is the world’s first private cord blood bank. More than 500,000
parents from 87 countries have entrusted Cryo-Cell International
with their baby’s cord blood and cord tissue stem cells. In
addition to its private bank, Cryo-Cell International has a public
banking program in partnership with Duke University. Cryo-Cell’s
public bank has provided cord blood for more than 600
transplantations and operates cord blood donation sites across the
U.S in prominent hospitals such as Cedars–Sinai Hospital in Los
Angeles and Baptist Hospital in Miami. Cryo-Cell’s facility is FDA
registered, cGMP-/cGTP-compliant and licensed in all states
requiring licensure. Besides being AABB accredited as a cord blood
facility, Cryo-Cell was also the first U.S. (for private use only)
cord blood bank to receive FACT accreditation for adhering to the
most stringent cord blood quality standards set by any
internationally recognized, independent accrediting organization.
Cryo-Cell owns the exclusive rights to PrepaCyte-CB, the
industry’s most advanced cord blood processing technology.
Cryo-Cell’s mission is to provide the premier
cord blood and cord tissue cryopreservation services and to
develop, manufacture and administer cellular therapies to
significantly improve the lives of patients worldwide. In February
2021, Cryo-Cell entered into a license agreement with Duke
University that transformed Cryo-Cell into an autonomous,
vertically integrated cellular therapy company.
For more information, please visit
ir.cryo-cell.com.
Forward-Looking Statements
Statements herein the terms “believe”,
“intends”, “projects”, “anticipates”, “expects”, and similar
expressions as used are intended to reflect “forward-looking
statements” of the Company. The information contained herein is
subject to various risks, uncertainties and other factors that
could cause actual results to differ materially from the results
anticipated in such forward-looking statements or paragraphs, many
of which are outside the control of the Company. These
uncertainties and other factors include the impact of the COVID-19
pandemic on our sales, operations and supply chain, the success of
the Company’s global expansion initiatives and product
diversification, the Company’s actual future ownership stake in
future therapies emerging from its collaborative research
partnerships, the success related to its IP portfolio, the
Company’s future competitive position in stem cell innovation,
future success of its core business and the competitive impact of
public cord blood banking on the Company’s business, the success of
the Company’s initiative to expand its core business units to
include biopharmaceutical manufacturing and operating clinics, the
uncertainty of profitability from its biopharmaceutical
manufacturing and operating clinics, the Company’s ability to
minimize future costs to the Company related to R&D initiatives
and collaborations and the success of such initiatives and
collaborations, the success and enforceability of the Company’s
umbilical cord blood and cord tissue license agreements, together
with the associated intellectual property and their ability to
provide the Company with royalty fees, and those risks and
uncertainties contained in risk factors described in documents the
Company files from time to time with the Securities and Exchange
Commission, including the most recent Annual Report on Form 10-K,
Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K
filed by the Company. The Company disclaims any obligations to
subsequently revise any forward-looking statements to reflect
events or circumstances after the date of such statements.
Contact:Irene
Smith813-749-2102Ismith@cryo-cell.com
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